2015-09966. Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice entitled “Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop” that appeared in the Federal Register of April 17, 2015 (80 FR 21248). The document announced a public workshop. The document was published with the incorrect title. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Leslie Wheelock, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4345, Silver Spring, MD, 301-796-8450, FAX: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of April 17, 2015, in FR Doc. 2015-08846, on page 21248 the following correction(s) is/are made:

1. On page 21248, in the second column, starting at the sixth sentence of the first paragraph, the title “Methodological Considerations to Address Unmeasured Information About Important Health Factors in Pharmacoepidemiology Studies that Rely on Electronic Healthcare Databases to Evaluate the Safety of Regulated Pharmaceutical Products in the Postapproval Setting” is corrected to read “Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases.”

Dated: April 23, 2015.

Peter Lurie,

Associate Commissioner for Public Health Strategy and Analysis.